Harmony Biosciences Holdings, Inc.

Good morning, everyone. My name is Todd, and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences' fourth quarter and full year 2022 financial results conference call. All participants have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question at that time, please press star one on your telephone keypad. Please be advised that today's conference may be recorded. Lastly, if you should require operator assistance, please press star zero. I will now turn the call over to Phuiz Sanai, head of investor relations. Please go ahead.

Phuiz Sanai Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' fourth quarter and full year 2022 financial results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany our discussion today, including a reconciliation of our GAAP to non-GAAP financial measures. At this stage of our life cycle, we believe non-GAAP financial results better represent the underlying business performance. Our presenters on today's call are Dr. Jeffrey Dano, Interim CEO and Chief Medical Officer, Jeffrey Dirks, Chief Commercial Officer, and Sandeep Kapadia, Chief Financial Officer. Moving on to slide two. As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially and we undertake no obligation to update these statements even if circumstances change. We encourage you to consult the risk factors referenced in our SEC filings for additional details. I would now like to turn the call over to Dr. Jeffrey Dana. Jeff?

Thank you, Louis, and thank you, everyone, for joining our conference call today. We delivered another strong quarter in Q4, finishing the year with continued momentum in our commercial business for Wacix, as well as in the advancement of our clinical development programs for Pitolisin. We are excited for 2023 and remain confident in the ongoing execution of our three-pillar growth strategy to further evolve Harmony into a leading rare disease company focused on delivering innovative therapies for patients living with rare neurological diseases. Harmony remains a growth story with a focus on advancement of our life cycle management programs for Pitocin and acquisition of new assets to build out our pipeline to drive additional growth. With that as our focus, I am excited to lead the company forward. After 12 years as a practicing neurologist taking care of patients, followed by 25 years in the industry touching every aspect of the business, I bring a unique perspective to the development and commercialization of innovative treatments that address major unmet medical need. I have seen the impact that these treatments can have on patients and their families, and I'm proud of the progress we have made. I also know that Harmony is poised for continued growth with our goal to help even more patients living with rare neurological diseases. I will now briefly highlight our progress on each of the three pillars of our growth strategy, in the context of Q4 2022 performance. Starting with pillar one, which is to optimize the commercial performance of WCAGX. We delivered WCAGX net revenue for the fourth quarter and full year 2022 of $128.3 million and $437.9 million respectively, representing an increase of 41% and 43% year over year. Our performance reflects the strong commercial execution by our team, the underlying demand for WCAGS, and the significant unmet need that remains in the narcolepsy market. For 2023, we expect continued growth for WCAGS and believe that the vast market opportunity which remains in narcolepsy, along with the differentiated product profile of WCAGS, provides us with the ability to grow WCAGS for years to come. At Harmony, this also translates into an opportunity to help even more adult patients living with narcolepsy. Moving to Pillar 2, which is to expand the clinical utility of Pitocin beyond narcolepsy. We are extremely pleased with the progress that we have made across all our pipeline and life cycle management programs, and I will provide more details on these during the clinical update later in the call. Briefly, In idiopathic hypersomnia, or IH, we continue to see strong momentum in our phase three in tune study. This opportunity, if successful, could be the next potential new indication for Pitocin. In Prader-Willi syndrome, or PWS, we are analyzing the full data set from our phase two proof of concept study in preparation for an end of phase two meeting with the FDA. It is our intent to advance the PWS program to a phase three trial. Overall, our life cycle management programs for Pitocin in total could address unmet medical needs in up to 100,000 diagnosed patients living with IH, PWS, and myotonic dystrophy. An opportunity that is successful would more than double our diagnosed patient opportunity. We are committed to advancing these development programs and are hopeful that these efforts could lead to additional new indications for Pitocin and address the unmet medical needs in these patient populations. And finally, pillar three, acquiring new assets through business development to expand our portfolio beyond WACICS. Our dedicated business development team has been actively assessing the landscape as it is our intent to build out a broad pipeline of rare orphan neurology assets and or assets in other neurological diseases where we can leverage our existing expertise and infrastructure. To achieve this, we intend to leverage our strong financial position to acquire additional assets across a range of development stages, including both early and later stage, with the potential to launch both during and after the WCAG life cycle. We are in a solid position to execute on Pillar 3 as our business fundamentals with WCAG remain strong, and we ended the year with approximately $346 million in cash, cash equivalents, and investment securities. Overall, I'm extremely pleased with the progress that our team has made on our three pillar growth strategy. We remain very confident in WCAG being a potential $1 billion plus franchise in the coming years by an narcolepsy and additional indications, and are truly excited for 2023, during which our team will remain focused on executional excellence. I will now turn the call over to Jeffrey Dirks, our Chief Commercial Officer, to provide more details on our commercial performance. Jeff?